Plasma Lipids In-Vitro Filtering Method And Apparatus

ABSTRACT

An in-vitro blood plasma lipids filtering method includes the following steps: separating out the blood plasma from the blood collection; flushing the apparatus carrying out the method with saline solution; controlling the temperature and pressure of the blood plasma; passing the blood plasma to screening procedure for filtering; and feeding the blood plasma back to the blood. The method is clearly effective and accurate, quick response indication, more secure and safer, more tolerant, and the treatment time is short.

TECHNICAL FIELD OF THE INVENTION

The present invention relates to in-vitro blood plasma lipids filteringmethod and apparatus, and more particularly relates to in-vitro bloodplasma lipids filtering method and apparatus.

BACKGROUND OF THE INVENTION

It is well known, with increasing living standards, the high-bloodlipids has already become a universal disease. According to World HealthOrganization statistics, all over the world there are approximately 15million mortality cases every year from cardio-cerebral-vasculardiseases, which is more than 50% of the total mortality rate.

The blood lipids are referring to the fat content of the blood, usuallyreferring to the cholesterol and triglyceride. The blood lipids areimportant to the human body growth, especially in cell formation andbody metabolism. The hyperlipidemia is referring to the excessively highblood level of cholesterol (TC), the triglyceride (TG), or thelow-density lipoprotein cholesterol (LDL-C), in modern medicalterminology referred to as abnormal blood lipids.

The abnormal blood lipids lead to atherosclerosis, an importantdangerous factor of coronary disease. Famous FRAMINGHAM studies proventhat lowering TC 1% reduces 2% of CVE. Reducing TC and LDL-C isimportant in controlling and preventing coronary diseases. In braininfarction patients, patients with Blood Hypervisicosity Syndrome (HBS)formation rate reaches as high as 63.7%.

Regarding diseases caused as a result of high blood lipids, the drugtreatment thus far has proven to be unsatisfying. At present, withbiological technology progression, leading to the filtering method usingin-vitro blood plasma to prevent and control diseases caused by highblood lipids (cholesterol, triglyceride, low-density lipoprotein andchyle-cholesterol). In-vitro blood plasma filtering method is graduallybecoming the direction of research and development in biological andmedical science.

In order to reduce blood lipids quickly, lipid reduction apparatus hasalready obtained clinical use. However, an apparatus of such kindusually uses physical chemistry method to carry on the lipid reductionprocess. Lipid reduction via lipid reducing apparatus is more effectiveand direct, in comparison with drug treatment to reduce blood plasmalipids. An apparatus of such kind is still unsatisfactory, and certainlyhas safety concerns.

At present, the main clinical use is a German apparatus, and this lipidreduction apparatus first treats the patient's blood plasma by achemical process to adjust the PH value, and then filters the bloodplasma lipids after the chemical precipitation process. Utilizing thisapparatus to filter the blood plasma lipids usually takes three hours tocomplete. Moreover, after two filtering processes, the lipid reductioneffect is also reduced to only 30%-50%. Especially, after chemicalprocessing, the hemoglutination in blood plasma may be damaged or lostas a result. In addition, this apparatus is currently very expensive,and the operational procedure is complex.

SUMMARY OF THE INVENTION

The present invention provides an in-vitro blood plasma lipids filteringmethod, which overcomes the above-mentioned technical difficulty andinsufficiency.

An objective of the present invention is to resolve and provide atechnology which is more direct and effective, and also provides a safeblood plasma lipids removal procedure.

In accordance with an aspect of the present invention, the presentinvention provides an in-vitro blood plasma lipids filtering method,comprising the following steps: collecting the blood and separating outthe blood plasma, carrying out saline solution treatment of theapparatus, carrying out blood plasma peristalsis, temperature andpressure control, passing the blood plasma through to screeningprocedure, collect post-filtered blood plasma back into the blood.

During the filtering process, the collected blood is gradually treatedand separated out. Each separation separates out about 150-250milliliters of the blood plasma. The blood plasma passes through thescreening procedure about 20-30 milliliters every minute. In theabove-described screening procedure, pressure is controlled below 60KPa. Adding heat to the blood plasma and the temperature is just aboutequal to the body temperature.

The above described blood plasma lipids screening procedure comprisesthree thin films or membrane, wherein a first film may be a membranewhich has filter aperture pores of about 0.3 to 0.65 microns andcomprises a lipid absorptive material; a second film is a membrane whichhas filter aperture pores of about 0.3 microns; and a third film is amembrane which has filter aperture pores of about 0.2 microns and ismade of nylon as the base material. In between the second and third thinfilms, there contains one or multiple layers of the first thin film. Thelipid absorptive material used is the silicon oxide pellets.

Another objective of the present invention is to provide an in-vitroplasma lipids screening procedure technology, which is more direct andeffective, and also provides a safe blood plasma lipids removalprocedure.

In accordance with an aspect of the present invention, the presentinvention provides an in-vitro blood plasma lipids screening procedure,comprising: a blood collecting device, a blood separating device, apre-filtered blood plasma bag, a blood lipids screening procedure, apost-filtered blood plasma bag as well as the blood plasma feedbackdevice. These devices are connected via pipelines and/or tubes, and thepipelines and tubes are also connected with a peristaltic pump. Inaddition, pressure and temperature control devices are installed amongthe pipelines and tubes. The in-vitro blood plasma lipids screeningprocedure also includes saline solution treatment bag and waste salinesolution bag. The saline solution treatment bag is connected to anoutlet of the pre-filtered blood plasma bag, and the waste salinesolution bag is connected to an entrance of post-filtered blood plasmabag.

The above-mentioned pre-filtered blood plasma bag contains an automaticweight or volume detector device, and transmits a signal when the bloodplasma bag is full to the blood separating device or the bloodcollecting device, thereby triggers a stop response. The volume of thepre-filtered blood plasma bag is about 150-250 milliliters.

The above-mentioned pressure control device can read out the currentpressure inside the pipeline tube. The pressure control device controlsthe pressure to be below 60 KPa. The rotational speed of the peristalticpump is controlled to maintain a flow rate of the blood plasma at about20-30 milliliters every minute.

The above-mentioned temperature control device is installed within thescreening procedure, so that the highest heating temperature iscontrolled at 38° C.

The above described blood plasma lipids screening procedure comprisesthree thin films or membrane, wherein a first film may be a membranewhich has filter aperture pores of about 0.3 to 0.65 microns andcomprises a lipid absorptive material; a second film is a type ofmembrane which has filter aperture pores of about 0.3 microns; and athird film is a membrane which has filter aperture pores of about 0.2microns and is made of nylon as the base material. In between the secondand third thin films, there contains one or multiple layers of the firstthin film. The lipid absorptive material used is the silicon oxidepellets.

The present invention can chemically remove the blood lipids, and thusis suitable to use in cases of high blood lipids diseases that are notsuitable for drub treatment, such as in high cholesterol blood level,hypertriglyceridemia, high-and-low-density lipoproteinemia, BloodHypervisicosity Syndrome (BHS), and so on. The present invention isobviously effective in removing blood fibrinogen, preventing stroke, andreducing blood viscosity. The present invention can remove about 50% ofblood lipids in one time filtering, and moreover, may be repeatedlycarried out numerous times.

The present invention utilizes the pure physics affinity with thenatural adsorption method; therefore, the present invention is safer,securer, and more tolerant. During treatment, patients generally havenot shown obvious discomfort. In addition, the treatment time is shortand patients usually spend approximately two hours per treatment.Moreover, the operational procedure is simple and requires minimalsupervision of specialists or special trainings.

BRIEF DESCRIPTION OF THE DRAWINGS

A detailed description will be given with respect to a preferredembodiment of the present invention and the best mode for carrying outthe present invention for further explanation to this invention withreference to the sole drawing,

FIG. 1, which is a schematic illustration showing an implementationexample of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT AND THE BEST MODE FORCARRYING OUT THE PRESENT INVENTION

The present invention will be further described in details inconjunction with the accompanying drawing. Referring to FIG. 1, which isa schematic illustration showing an implementation example of thepresent invention, a blood separating device is first employed, whichutilizes a centrifugal separation method to separate the blood plasmafrom a patients' blood collecting bag. Other cellular components arefeedback to the patients in a feedback loop. The separated blood plasmaenters a pre-filtered blood plasma bag, and a saline solution bag forpre-treating the device and tubes is connected to the device at anoutlet of the pre-filtered blood plasma bag.

The pre-treatment saline solution or blood flows through the pipelinetubes to the peristaltic pump. The peristaltic pump provides power andpressure for the in-vitro loop device. An end terminal of the in-vitroloop device has an adjustable pressure control to adjust and controlpressure, ensuring a safer and comfortable treatment process. Then thepipeline tube is connected to plasma lipids screening procedure, and thescreening procedure filter membrane is evenly distributed with massivefunctional particles. Post-centrifugal mixed-particles blood plasmaflows through the filter membrane so that TC, TG, LDL and so on, arefirmly attracted and attached on the filter membrane. Thereby, theunclouded, thus purified blood plasma flows out screening procedure, andenters through the pipeline tube into post-filtered blood plasma bag.The post-filtered blood plasma bag entrance is connected with a pipelinetube to the waste saline solution bag. During saline solution treatment,the pipeline tube to post-filtered blood plasma bag connection isshut-off, so that post-filtered blood plasma is not mixed with thesaline solution, and the treatment saline solution flows to the wastesaline solution bag. During the blood filtering process, shutting-offthe pipeline to waste saline solution bag will also ensure that thepost-treatment blood plasma flows through to the post-filtered bloodplasma bag. The blood plasma passes through a temperature control deviceto maintain a constant temperature of the blood plasma. Thetemperature-controlled blood plasma is then looped back to the body viaa blood plasma feedback device.

In the above-mentioned device, the blood colleting device collects theblood and also allows the blood cellular components to be fed back in aloop. Therefore the device may be a generic blood-collecting device, orthe device may be specially designed double-barrel single-needle device.Certainly, the device may be designed to independently draw blood andwith the feature of feedback pipeline tube and needle. However, a devicelike such will require that the patients to be inserted twice withneedles, and presumably will increase pain on the patients.

The separated blood plasma flows into a pre-filtered blood plasma bag.The said blood plasma bag has a certain volume or weight, so that whenthe blood plasma inside the blood plasma bag achieves a certain volumeor weight, the blood separating device and the blood collecting devicewill stop. In some implementation examples, the blood plasma bag has anautomatic volume or weight detection device, which transmits a signalwhen the blood plasma is full, so that the blood separating device andthe blood collecting device are triggered to shut-off. Generally, atypical volume of a blood plasma bag is about 200 milliliters. The saidvolume satisfies filtering efficiency and ensures that patients feelscomfortable, and causes no damage to danger to the patients.

The present invention also has a saline solution treatment device, thesaline solution treatment bag parallel with the pre-filtered bloodplasma bag are connected to the lateral device. Moreover, just prior tothe entrance of the post-filtered blood plasma bag, there exists apipeline tube connecting to the waste saline solution bag. Before thestart of the apparatus set, the blood plasma bag is shut-off, the salinesolution inside the saline solution treatment bag flushes the pipelinetube and the device, and the post-flushing saline solution enters thewaste saline solution bag. Closure of the saline solution bag is madeafter the flushing is completed. The blood plasma bag is open to allowblood plasma to flow into pipeline tube. The flushing of saline solutionis due to the following considerations. First, typical medical devicesand pipeline tubes are disinfected daily or after each use. Thesedisinfectants, such as Oxirane, are generally harmful to the human body,and can remain in the pipeline tube in varying degrees. The salinesolution treatment can wash off these harmful residues. Next, the salinesolution treatment can be used to check the system's seal-proof quality,in order to guard against leakage occurring during process. Again, afterthe closure of the saline solution bag, there may be saline solutionremaining in the pipeline tube and the apparatus, and the residualsaline solution can be used to supplement patient's blood capacity.After post-filtration process, the blood plasma is exchanged to preventthe loss of blood plasma. The saline solution treatment bag and thewaste saline solution bag may also be installed in other parts of theapparatus that can totally wash-out the pipeline tube and device.

Blood plasma in the pre-filtered blood plasma bag flows to theperistaltic pump, and the peristaltic pump provides the pipeline tubewith power for liquid movement. In the back of the peristaltic pump,there is a pressure control device, which can read out the currentpipeline tube pressure. In some implementation examples, the pressurecontrol device may also adjust the rotational speed of the peristalticpump. The peristaltic pump rotational speed produces flowing power forthe blood plasma, and the blood plasma later during screening procedureis subject to resistance and in turn induces pressure buildup. Thepressure, if too large, may harm the apparatus, and simultaneously canalso cause the patient to feel ill. However, the peristaltic pumprotational speed, if too slow, causes the blood plasma flow speed to beslow, and can lead to lengthening the filtration time. Numerousimplementation examples prove that when the speed of flow is about 20-30milliliters per minute, the lipid reduction is more effective.Therefore, general peristaltic pump rotational speed is set in advanceat this level. However, due to the fact that some patients' blood plasmadensity is higher, and may be more difficult to pass screening process,and thus may induce tremendous pressure. When the pressure achieves alevel which could possibly harm the apparatus or make the patients feelill, the pressure control device will indicate this pressure value, andthe monitoring staff can reduce the peristaltic pump speed to reducepressure. When the pressure control device can control the peristalticpump rotational speed, the process will be able to completeautomatically. Therefore, the pressure control can be done by a simplepressure gauge or an automatic velocity regulation system comprising apressure sensory device and speed controlled peristaltic pump. In anexample of the present invention, the pressure marginal value is about60 KPa. Because pressure production and density level of blood plasmaare related, through monitoring reading value on the pressure controldevice, patient's blood density and condition may be determined.

The blood plasma, after peristaltic pump process, enters the bloodplasma lipids screening procedure. The blood plasma lipids screeningprocedure is composed of multi-layers of thin film membranes, of which afirst film may be a membrane which has filter aperture pores of about0.3 to 0.65 microns and comprises a lipid absorptive material. The firstmembrane may attract the fatty contents in the blood plasma, and thelipid absorptive material may be of the silicon oxide pellet. Inaddition, the first membrane filters out other impure particles that arebigger than the filter pores. A second film is a membrane which hasfilter aperture pores of about 0.3 microns. The second membrane canfilter out bacterium and chyle-lipoprotein, because bacterium andchyle-lipoprotein have diameters greater than 0.3 microns. A third filmis a membrane which has filter aperture pores of about 0.2 microns andis made of nylon as the base material. The third membrane filters outany and all foreign particles generated from the first and secondfiltering processes, such matters like thin film wood-pulp material oradsorptive particles.

The use and number of membrane layers depend on the adsorptive abilityand the volume of blood to be filtered must be taken into considerationtogether. That is, if one layer is insufficient, and multiple layers maybe considered to use in stead. In addition, other lipid adsorptivemembranes may be placed in between the above-mentioned second and thirdmembranes to make up the insufficiency of the first, second, or thirdmembranes.

The blood plasma, after filtering process, flows into the post-filteredblood plasma bag and further goes through the blood plasma feedbackdevice and is fed back to the patients. A temperature control devicelocated on the pipeline tube or the apparatus maintains that the bloodplasma is at a temperature approximately close to the body temperature.The advantage is that patients are as close to natural condition aspossible and thus are comfortable. This temperature control device maybe a heating plate with the highest heating temperature controlled atabout 38° C. The temperature control device may be placed any where inthe pipeline tube or the device which is suitable for heating. Theoptimal location of the hot plate is suggested in the screeningprocedure.

It is to be understood, however, that even though numerouscharacteristics and advantages of the present invention have been setforth in the foregoing description, together with details of the methodand function of the invention, the disclosure is illustrative only,various modifications and changes may be made by persons skilled in thisart, especially in arrangement of parts within the principles of theinvention to the full extent indicated by the broad general meaning ofthe terms in which the appended claims are expressed. It is intendedthat the present invention should not be limited to the particularforms, and that all modifications and changes which maintain the spiritand realm of the present invention are within the scope as defined inthe appended claims.

1. A blood plasma lipids in-vitro filtering method, comprising thefollowing steps: separating blood plasma from collected blood; carryingout flushing with saline solution; controlling temperature and pressureof the blood plasma; passing the blood plasma to screening procedure forfiltering; and feeding the blood plasma back to the blood after thefiltering step.
 2. The method as claimed in claim 1, wherein theseparating step comprises a stepwise separation process for separatingthe blood plasma at about 150-250 milliliters of blood plasma each time.3. The method as claimed in claim 1, wherein the blood plasma passes tothe screening procedure at a speed of 20-30 milliliters per minute. 4.The method as claimed in claim 1, wherein in the screening procedure,pressure is controlled below 60 KPa.
 5. The method as claimed in claim 1further comprising a step of making temperature of the blood plasmaapproximately equal to body temperature.
 6. The method as claimed inclaim 1, wherein the screening procedure comprises three films, of whicha first film is membrane that has filter aperture pores of about 0.3 to0.65 microns and comprises a lipid absorptive material, a second film isa membrane that has filter aperture pores of about 0.3 microns, and athird film is a membrane that has filter aperture pore of about 0.2microns and comprises nylon as a base material.
 7. The method as claimedin claim 6, wherein at least one first film is interposed between thesecond and third films.
 8. The method as claimed in claim 6 or 7,wherein the lipid absorptive material comprises silicon oxide pellets.9. An in-vitro blood plasma lipids screening procedure comprising: ablood collecting device, a blood separating device, a pre-filtered bloodplasma bag, a blood lipids screening procedure, a post-filtered bloodplasma bag, and a blood plasma feedback device, which are connected viatubes, and the tubes being also connected with a peristaltic pump,pressure and temperature control devices being installed among thetubes, the in-vitro blood plasma lipids screening procedure furthercomprising saline solution treatment bag and waste saline solution bag,the saline solution treatment bag being connected to an outlet of thepre-filtered blood plasma bag, and the waste saline solution bag beingconnected to an entrance of post-filtered blood plasma bag.
 10. Thein-vitro blood plasma lipids screening procedure as claimed in claim 9,wherein the pre-filtered blood plasma bag comprises an automaticweight/volume detection device, which selectively transmits a signalindicating that the blood plasma bag is full to the blood separatingdevice and the blood collecting device, thereby triggering a stopresponse.
 11. The in-vitro blood plasma lipids screening procedure asclaimed in claim 9, wherein the pre-filtered blood plasma bag has avolume of about 150-250 milliliters.
 12. The in-vitro blood plasmalipids screening procedure as claimed in claim 9, wherein the pressurecontrol device reads out a current pressure inside the tube.
 13. Thein-vitro blood plasma lipids screening procedure as claimed in claim 9,wherein the peristaltic pump is controlled to have a rotational speedthat induces a flow rate of the blood plasma at about 20-30 millilitersevery minute.
 14. The in-vitro blood plasma lipids screening procedureas claimed in claim 9, wherein the pressure control device controls thepressure to be below 60 KPa.
 15. The in-vitro blood plasma lipidsscreening procedure as claimed in claim 9, wherein the temperaturecontrol device in installed in the screening procedure.
 16. The in-vitroblood plasma lipids screening procedure as claimed in claim 9, whereinthe temperature control device is operable to have a highest heatingtemperature at 38° C.
 17. The in-vitro blood plasma lipids screeningprocedure as claimed in claim 9, wherein the blood lipids screeningprocedure comprises three films of which a first film is a membranewhich has filter aperture pore of about 0.3 to 0.65 microns andcomprises a lipid absorptive material, a second film is a membrane whichhas filter aperture pore of about 0.3 microns, and a third film is amembrane which has filter aperture pore of about 0.2 microns and is madeof nylon as a base material.
 18. The in-vitro blood plasma lipidsscreening procedure as claimed in claim 17, wherein at least one firstfilm is interposed between the second and third films.
 19. The in-vitroblood plasma liquids screening procedure as claimed in claim 17 or 18,wherein the lipid absorptive material comprises silicon oxide pellets.20. An application of the in-vitro blood plasma lipids screeningprocedure in treating apoplexy and stroke related cases.